AS-3XX Series Fingertip Pulse Oximeter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180685 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AS-3XX Series Fingertip Pulse Oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin. It includes models AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L and AS-311.
The device is supplied by Xiamen Acurio Instruments Co., Ltd. and is intended for spot-checking use. It received FDA 510(k) clearance with K number K180685 on November 29, 2018, and is classified under product code DQA.
Frequently asked questions
What is the AS-3XX Series Fingertip Pulse Oximeter used for?
The AS-3XX Series Fingertip Pulse Oximeter is a portable non-invasive device designed for spot-checking oxygen saturation of arterial hemoglobin. It helps monitor blood oxygen levels quickly and conveniently in various healthcare settings.
What models are available in the AS-3XX Series?
The AS-3XX Series includes multiple models: AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L, and AS-311. Each model may have specific features or variations to meet different clinical needs.
Is the AS-3XX Series Fingertip Pulse Oximeter a single-use device?
The device is intended for spot-checking use, but the description doesn't specify whether it's single-use or reusable. Users should refer to the manufacturer's instructions for proper usage and sterilization guidelines.
What regulatory approvals does the AS-3XX Series have?
The AS-3XX Series Fingertip Pulse Oximeter received FDA 510(k) clearance with K number K180685 on November 29, 2018. It is classified under product code DQA and was determined to be substantially equivalent to predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AS-3XX Series Fingertip Pulse Oximeter by Xiamen Acurio Instruments Co ..., AS-3XX Series Fingertip Pulse Oximeter (K180685) - Innolitics, AS-3XX Series Fingertip Pulse Oximeter
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180685 | Class II | Active |
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Manufacturer
- Manufacturer
- Xiamen Acurio Instruments Co., Ltd.
Sources (1)
- FDA 510(k) K180685 24 fields · synced Sep 28, 2026